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FDA 510(k)

SIME HEALTH SIME HYPOALLERGENIC

K-Number: K931491 · 1993-10-15

ApplicantSime Health, Ltd.
Decision Date1993-10-15
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SIME HEALTH SIME HYPOALLERGENIC is the device name listed in this FDA 510(k) record. The listed applicant is Sime Health, Ltd.. It received FDA 510(k) clearance on 1993-10-15 under 510(k) number K931491. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIME HEALTH SIME HYPOALLERGENIC?

SIME HEALTH SIME HYPOALLERGENIC is a medical device that received FDA 510(k) clearance on 1993-10-15. The listed applicant is Sime Health, Ltd.. The 510(k) number is K931491.

When did SIME HEALTH SIME HYPOALLERGENIC receive FDA 510(k) clearance?

SIME HEALTH SIME HYPOALLERGENIC received FDA 510(k) clearance on 1993-10-15, under 510(k) number K931491.

Who is the listed applicant for SIME HEALTH SIME HYPOALLERGENIC?

The FDA 510(k) record lists Sime Health, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIME HEALTH SIME HYPOALLERGENIC?

The FDA product code for SIME HEALTH SIME HYPOALLERGENIC is LYY.

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Other records listing Sime Health, Ltd. as applicant

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Related Devices (Code: LYY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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